HBVAXPRO Suspension for injection (2022)
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Περιεχόμενα
Name of the medicinal product
HBVAXPRO 5 micrograms, suspension for injection. Hepatitis B vaccine (recombinant DNA).
Qualitative and quantitative composition
<u>One dose (0.5 ml) contains:</u> Hepatitis B virus surface antigen, recombinant (HBsAg)* 5 micrograms. Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+). * produced in Saccharomyces ...
Pharmaceutical form
Suspension for injection. Slightly opaque white suspension.
Therapeutic indications
HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis ...
Posology and method of administration
Posology Individuals from birth through 15 years of age: 1 dose (0.5 ml) at each injection: Primary vaccination A course of vaccination should include at least three injections. Two primary immunisation ...
Contraindications
History of hypersensitivity to the active substance, or to any of the excipients, or trace residuals (e.g. formaldehyde and potassium thiocyanate), see sections 6.1 and 2. Vaccination should be postponed ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, ...
Interaction with other medicinal products and other forms of interaction
This vaccine can be administered: with hepatitis B immunoglobulin, at a separate injection site. to complete a primary immunisation course or as a booster dose in subjects who have previously received ...
Fertility, pregnancy and lactation
Fertility HBVAXPRO has not been evaluated in fertility studies. Pregnancy There is no clinical data on the use of HBVAXPRO on pregnant women. The vaccine should be used during pregnancy only if the potential ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.
Undesirable effects
a. Summary of the safety profile The most common side effects seen are injection-site reactions: transient soreness, erythema, induration. b. Tabulated summary of adverse reactions The following undesirable ...
Overdose
There have been reports of administration of higher than recommended doses of HBVAXPRO. In general, the adverse event profile reported with overdose was comparable to that observed with the recommended ...
Pharmacodynamic properties
Pharmacotherapeutic group: anti-infectious ATC code: J07BC01 The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Development of an antibody titre against ...
Pharmacokinetic properties
Not applicable.
Preclinical safety data
Animal reproduction studies have not been conducted.
List of excipients
Sodium chloride Borax Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Store in the original package in order to protect from light. HBVAXPRO should be administered as soon as possible after being removed from refrigeration. ...
Nature and contents of container
0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps. Pack size of 1, 10. 0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) ...
Special precautions for disposal and other handling
The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration. If these conditions exist, the product should not be administered. ...
Marketing authorization holder
MSD VACCINS, 162 avenue Jean Jaurès, 69007, Lyon, France
Marketing authorization number(s)
EU/1/01/183/001 EU/1/01/183/018 EU/1/01/183/019
Date of first authorization / renewal of the authorization
Date of first authorisation: 27/04/2001 Date of last renewal: 17/03/2011
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